Cannabis based therapeutic and method of use

ABSTRACT

The present invention is a compound comprising a cannabis portion and at least one of a progestin portion and a progesterone portion. The compound may optionally also include an NSAID component. The compound may take for instance the form of a pill or pellet (for oral internal use or for subdermal implantation), an injectable solution, or a suppository. The compound is intended for use in treating subjects having or being at increased risk—especially genetically determined risk—of developing endometriosis. The compound may also be used for treating other disorders or as a contraceptive.

CROSS REFERENCE TO RELATED APPLICATIONS

This US nonprovisional utility patent application claims the benefitunder 35 USC §119(e) of U.S. provisional application No. 61/825,587filed May 21, 2013 which is expressly incorporated herein in itsentirety by this reference.

FIELD OF THE INVENTION

The present invention relates to therapeutics, and more especiallycannabis based therapeutics for use in treating those known to have orbe at increased risk of endometriosis and other ailments.

BACKGROUND OF THE INVENTION

Endometriosis is a common gynecological disorder. Many therapeuticsincluding progestins and uses of such therapeutics in the treatment ofendometriosis are well known. Examples of such therapeutics and methodsare taught in US patent application 20080306034 to Ward and in U.S.patent application Ser. No. 13/788,913 to Ward et al. which areincorporated herein in their entirety by this reference. Further, it hasbeen shown that the concurrent administration of both an NSAID(Nonsteroidal Anti-Inflammatory Drug) and a progestin can provide anincreased synergistic effect in the treatment of a disorder as comparedto what might be obtained by the administration of an NSAID and/or aprogestin separately. Moreover, such concurrent administration may allowfor reduced dosages of an NSAID and/or a progestin as compared to arequired dosage of an NSAID and a progestin administered separately. Anexample of such concurrent administration is taught in “Rodriguez, G Cet al, NSAIDs and progestins synergistically enhance cell death inovarian epithelial cells, AJOG, March 2012, pg 253e1-253e9” which isincorporated herein in its entirety by this reference. It is furtherknown that cannabis has been shown to reduce pain and/or reducesensitivity to pain and may have fewer or none of the side effects ofother NSAIDs (see Appxs A and B).

SUMMARY OF THE INVENTION

The present invention is a compound comprising a cannabis portion and atleast one of a progestin portion and a progesterone portion. Thecompound may optionally also include an NSAID portion (in addition toand separate from the cannabis based portion). For the purposes of thisinvention, where reference is used to an NSAID, unless indicatedotherwise, such NSAID shall be understood to be a separate and distinctcomponent from a cannabis component. The compound may take for instancethe form of a pill or pellet (for oral internal use or for subdermalimplantation), an injectable solution, or a suppository. The compound isintended for use in treating subjects having or being at increasedrisk—especially genetically determined risk—of developing endometriosis.The compound may also be used for treating other disorders such aschronic pain, and more especially chronic pelvic pain or as acontraceptive.

DETAILED DESCRIPTION OF THE INVENTION

Reference throughout this specification to “one embodiment,” “anembodiment,” or similar language means that a particular feature,structure, or characteristic described in connection with the embodimentis included in at least one embodiment of the present invention. Thus,appearances of the phrases “in one embodiment,” “in an embodiment,” andsimilar language throughout this specification may, but do notnecessarily, all refer to the same embodiment.

Furthermore, the described features, structures, or characteristics ofthe invention may be combined in any suitable manner in one or moreembodiments. In the following description, numerous specific details areincluded to provide a thorough understanding of embodiments of theinvention. One skilled in the relevant art will recognize, however, thatthe invention can be practiced without one or more of the specificdetails, or with other methods, components, materials, and so forth. Inother instances, well-known structures, materials, or operations are notshown or described in detail to avoid obscuring aspects of theinvention.

A first embodiment of the invention is a therapeutic compound for use intreating endometriosis and like disorders and preferably in pill formcomprising a compound including a cannabis component and at least one ofa progestin component and a progesterone component. The compound mayoptionally also include an NSAID component. In practice, a subject beingdetermined to have endometriosis or at increased risk of developingendometriosis, and more especially being determined to be geneticallypredisposed to increased risk of developing endometriosis, is orallyadministered a therapeutically effective amount of the compound so as toalleviate, cure, or prevent the symptoms of endometriosis. Thetherapeutic compound may be likewise administered for use as acontraceptive.

A second embodiment of the invention is a therapeutic compound for usein treating endometriosis and like disorders and preferably in pelletform comprising a compound including a cannabis component and at leastone of a progestin component and a progesterone component. The compoundmay optionally also include an NSAID component. In practice, a subjectbeing determined to have endometriosis or at increased risk ofdeveloping endometriosis, and more especially being determined to begenetically predisposed to increased risk of developing endometriosis,is administered a therapeutically effective amount of the compound byimplanting the compound subdermally into the subject so as to alleviate,cure, or prevent the symptoms of endometriosis. The therapeutic compoundmay be likewise administered for use as a contraceptive.

A third embodiment of the invention is a therapeutic compound for use intreating endometriosis and like disorders and preferably in solutionform comprising a compound including a cannabis component and at leastone of a progestin component and a progesterone component. The compoundmay optionally also include an NSAID component. In practice, a subjectbeing determined to have endometriosis or at increased risk ofdeveloping endometriosis, and more especially being determined to begenetically predisposed to increased risk of developing endometriosis,is administered a therapeutically effective amount of the compound byinjecting the compound subdermally into the subject so as to alleviate,cure, or prevent the symptoms of endometriosis. The therapeutic compoundmay be likewise administered for use as a contraceptive.

A fourth embodiment of the invention is a therapeutic compound for usein treating endometriosis and like disorders and preferably insuppository form comprising a compound including a cannabis componentand at least one of a progestin component and a progesterone component.The compound may optionally also include an NSAID component. Inpractice, a subject being determined to have endometriosis or atincreased risk of developing endometriosis, and more especially beingdetermined to be genetically predisposed to increased risk of developingendometriosis, is administered a therapeutically effective amount of thecompound by placing the compound into a body orifice of the subject(e.g. vaginally or rectally) so as to alleviate, cure, or prevent thesymptoms of endometriosis. The therapeutic compound may be likewiseadministered for use as a contraceptive.

It shall be noted that the progestin disclosed herein may include any ofa first generation progestin (estrane) including norethindrone,norethynodrel, norethindrone acetate, and ethynodiol diacetate, a secondgeneration progestin (gonane) including levonorgestrel, norethisterone,and norgestrel, a third generation progestin (gonane) includingdesogestrel, gestodene, norgestimate, drospirenone, and a fourthgeneration progestin including dienogest, nestorone, nomegestrolacetate, and trimegestone. It shall also be noted that the progesteronedisclosed herein may include tanaproget. It shall also be noted that thecannabis component is preferably free of a THC portion. It shall also benoted that the cannabis component may include any of a nabilone,dronabinol, and nabiximols. It shall also be noted that the NSAIDdisclosed herein may include any of a salicylate including aspirin(acetylsalicylic acid), diflunisal, and salsalate, a propionic acidderivative including ibuprofen, dexibuprofen, naproxen, fenoprofen,ketoprofen, dexketoprofen, flurbiprofen, oxaprozin, and loxoprofen, anacetic acid derivative including indomethacin, tolmetin, sulindac,etodolac, ketorolac, diclofenac, and nabumetone, an enolic acid (oxicam)derivative including piroxicam, meloxicam, tenoxicam, droxicam,lornoxicam, and isoxicam, a fenamic acid derivative (fenamates)including efenamic acid, meclofenamic acid, flufenamic acid, andtolfenamic acid, a selective COX-2 inhibitor (Coxibs) includingcelecoxib, rofecoxib, valdecoxib, parecoxib, lumiracoxib, etoricoxib,and firocoxib (used in dogs and horses), a sulphonanilide includingnimesulide, an other NSAID including licofelone (acts by inhibiting LOX(lipooxygenase) & COX and hence known as LOX/COX inhibitor) and lysineclonixinate, and a natural NSAID including hyperforin, figwort, andcalcitriol (vitamin D). It shall also be noted that the compounddisclosed herein may include a biologic component including AMPION. Itshall also be noted that the therapeutic compound disclosed herein isalso useful in increasing dosage accuracy and administration convenienceas compared to concurrent administration of separate NSAID and progestinand/or progesterone components.

An exemplary therapeutic compound conforming with any of the disclosedembodiments may comprise for instance a compound including at least oneof nabilone, dronabinol, and nabiximols, and at least one of a progestincomponent and a progesterone component and optionally at least one ofnaproxen, meloxicam, and celecoxi. A further exemplary therapeuticcompound conforming with any of the disclosed embodiments may comprisefor instance a compound including at least one of nabilone, dronabinol,and nabiximols and at least one of a progestin component and aprogesterone component and optionally at least one of piroxicam,sulindac, and nabumetone. Still further an exemplary therapeuticcompound conforming with any of the disclosed embodiments may comprisefor instance a compound including 200 to 400 mg (milligrams) of nabiloneand 250 to 450 μg (micrograms) of norethindrone preferably administeredas a once daily dosage. Still further an exemplary therapeutic compoundconforming with any of the disclosed embodiments may comprise forinstance a compound including 200 to 400 mg (milligrams) of nabilone and250 to 450 μg (micrograms) of norethindrone preferably administered as aonce daily dosage. Still further an exemplary therapeutic compoundconforming with any of the disclosed embodiments may comprise forinstance a compound including approximately 300 mg of nabilone andapproximately 350 μg of norethindrone preferably administered as a oncedaily dosage.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

What is claimed is:
 1. A pharmaceutical pill or subdermally implantablepellet for treating a human suffering from endometriosis consistingessentially of therapeutically effective amounts of a component selectedfrom the group consisting of norethindrone, norethynodrel, norethindroneacetate, ethynodiol diacetate, levonorgestrel, norethisterone,norgestrel, desogestrel, gestodene, norgestimate, drospirenone,dienogest, drospirenone, nestorone, nomegestrol acetate, andtrimegestone, a component selected from the group consisting ofnabilone, dronabinol and nabiximol and tanaproget.